Multiple-detection kit for vaginitis, and preparation method thereof

A detection kit and technology for vaginitis, which is applied in the field of multiple detection kits for vaginitis and its preparation, can solve problems affecting detection, etc., achieve the effects of reducing procedures, increasing hydrophilicity, and reducing use costs

Pending Publication Date: 2017-11-24
山东康华生物医疗科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the components of vaginal secretions are complex and diverse, and the interfering substances in the secretions will affect the detection. Therefore, in view of the problems existing in the prior art, a multiple detection kit for detecting vaginitis is provided, and the detection kit is also established preparation method

Method used

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  • Multiple-detection kit for vaginitis, and preparation method thereof
  • Multiple-detection kit for vaginitis, and preparation method thereof
  • Multiple-detection kit for vaginitis, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A kind of vaginitis multiple detection kit, such as Figure 1-Figure 6 As shown, it includes a box body 1 and a box cover 2. The box body 1 is provided with a test card 3 and a sample processing solution bottle 4. The test card 3 includes a card cover 30 and a card body 31. The card body 31 is provided with a vaginal filler. The limit plate 310 of the test paper strip 5, the Candida albicans detection test strip 6 and the Trichomonas vaginalis detection test strip 7, the limit plate 310 is provided with a test strip placement mark (near the middle of the limit plate The square hole that is provided on one side of the limit plate 310), the two ends of the limit plate 310 are respectively provided with fixed baffles 311, and the three kinds of detection test strips are respectively provided with the first sample cushion layer 50 and the first sample cushion layer 50 that is connected to each other by overlapping. The second sample cushion layer 51, the colloidal gold laye...

Embodiment 2

[0068] A kind of preparation method of vaginitis multiple detection kit, comprises the following steps:

[0069] (1) Preparation of sample treatment solution

[0070] Dilute 0.5-1% w / v BSA 10-15mL, 1.0-2.0% w / v EDTA 3-5mL and 0.03-0.05% w / v sodium azide 1-3mL, dilute to volume with 20mM phosphate buffer to 100mL, adjust the pH value to 7.2-7.5, put them into reagent bottles respectively, and obtain the sample treatment solution;

[0071] (2) Preparation of sample pad pretreatment solution

[0072] Use 10-20g of PVP, 0.5-1%w / v casein 40-50mL, 5-8%w / v trehalose 10-15mL and 0.3-0.5%w / v Triton X-1001-2mL for Dilute to 1L with 20mM Tris and adjust the pH value to 8.0-8.2;

[0073] (3) Sample pad pretreatment

[0074] Cut the glass fiber to 25cm×30cm, soak it in the sample pad pretreatment solution in the above step (2), let it stand for 5-8 minutes after soaking completely, take it out, put it in the drying room to dry for 6 hours, and put it in a desiccant for storage spare; ...

Embodiment 3

[0098] By comparing with the gold standard "isolation and culture method", the clinical effectiveness of the vaginitis multiple detection kit was evaluated.

[0099] Table 1 Clinical performance indicators of Gardnerella vaginalis

[0100]

[0101] Sensitivity=100 / (100+9)×100%=91.7%

[0102] Specificity=295 / (16+295)×100%=94.9%

[0103] Power efficiency=(100+295) / (100+9+16+295)×100%=94.0%

[0104] The clinical performance index of table 2 Candida albicans

[0105]

[0106] Sensitivity=63 / (63+5)×100%=92.6%

[0107] Specificity=237 / (12+237)×100%=95.2%

[0108] Power efficiency = (63+237) / (63+5+12+237)×100%=94.6%

[0109] Table 3 Clinical performance indicators of Trichomonas vaginalis

[0110]

[0111] Sensitivity=34 / (34+3)×100%=91.9%

[0112] Specificity=158 / (10+158)×100%=94.0%

[0113] Power efficiency=(34+158) / (34+3+10+158)×100%=93.7%

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Abstract

The invention relates to the technical field of in vitro diagnosis, and concretely relates to a multiple-detection kit for vaginitis. The kit comprises a kit body and a kit cover, a detection card and a sample processing solution bottle are arranged in kit body, the detection card comprises a card cover and a card body, a Gardnerell avaginalis test strip, a Candida albicans test strip and a Trichomonas vaginalis test strip are arranged in the card body, and each of the Gardnerell avaginalis test strip, the Candida albicans test strip and the Trichomonas vaginalis test strip is provided with a first sample pad layer and a second sample pad layer treated with the sample pad treatment fluid. The kit can decompose and filter out interfering substances in vaginal secretions, so the sensitivity of the kit is improved.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnosis, in particular to a vaginitis multiple detection kit and a preparation method thereof. Background technique [0002] Vaginal infection is the most common gynecological infectious disease in clinical practice, and vaginitis is one of the typical clinical syndromes of vaginal infection, and the incidence rate remains high. Usually, the clinical manifestations and signs of vaginitis are similar, such as abnormal vaginal discharge, odor , itching, pain, and other discomforts. Among them, bacterial vaginosis, Candida albicans vaginitis and trichomonas vaginitis are common vaginal infections. [0003] Bacterial vaginosis is mainly a common disease caused by the disturbance of the ecological balance of the normal vaginal flora, the reduction or disappearance of the dominant bacteria Lactobacillus, and the excessive growth of Gardnerella vaginalis, anaerobic bacteria and other microorganisms; ...

Claims

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Application Information

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IPC IPC(8): G01N33/577G01N33/569G01N33/558
CPCG01N33/558G01N33/569G01N33/577
Inventor 杨致亭王鸿鑫刘根贤房克爽杨明霞
Owner 山东康华生物医疗科技股份有限公司
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